Reaction mass of sodium sulphate and disodium dodecanedioate and Dodecanoic acid, 12-amino-, sodium salt (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 June 2010 - Sept.2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to GLP and testing guideline (observed deviation was not considered to have compromised the validity of the results and study); adequate coherence between data, comments and conclusions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

temperature recorded in the animal room was sometimes outside of the target ranges specified in the study plan (up to 24°C)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

temperature recorded in the animal room was sometimes outside of the target ranges specified in the study plan (up to 24°C)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate

IUPAC Name:

Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate

Details on test material:

- Name of test material (as cited in study report): Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate
- Substance type: UVCB (substance of unknown or variable composition, complex reaction products or biological materials)
- Physical state: brown liquid
- Purity test date: 26 march 2009
- Lot/batch No.: T710/712
- Expiration date of the lot/batch: 20 September 2010
- Storage conditions of test material: at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder: Grimaud Frères Selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: on the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation:on the day of treatment, the animals had a mean body weight ± standard deviation of 2.7 ± 0.2 kg
- Housing: the animals were individually housed in Pajon cages (50 cm x 57 cm x 75 cm)
- Diet (e.g. ad libitum): free access to breeding pelleted diet “type 110”
- Water (e.g. ad libitum): tap water (filtered using a 0.22 µm filter) contained in bottles
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: 29 June 2010 To: 26 July 2010.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL of undiluted test item

Duration of treatment / exposure:

3 minutes, 1 hour, 4 hours.

Observation period:

For each exposure period, cutaneous reactions were evaluated approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then
daily until the reversibility of cutaneous reactions.

Number of animals:

Three males.

Details on study design:

TEST SITE
- Area of exposure: anterior left flank (application for 3 minutes), anterior right flank (application of 1 hour), posterior right flank (application for
4 hours).
- % coverage: 6 cm2
- Type of wrap if used: gauze pad held in place by a non-irritation semi occlusive dressing and a restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test item was wiped off by means of a moistened cotton pad
- Time after start of exposure: the test item was placed on a dry gauze pad, which was then applied to an area of the skin of approximately 6 cm2 of
the animals. The gauze pad was held in place by a non-irritation semi occlusive dressing and a restraining bandage.
For the 4-hour exposure, a dry gauze pad was applied to the opposite flank, which was acted as control.
After required period of contact with the skin, the dressings were removed.

SCORING SYSTEM:
Dermal irritation was evaluated for each animal according to the following scoring scale:

Erythema and eschar formation:
. no erythema 0
. very slight erythema (barely perceptible) 1
. well-defined erythema 2
. moderate to severe erythema 3
. severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Edema formation
. no edema 0
. very slight edema (barely perceptible) 1
. slight edema (edges of area well-defined by definite raising) 2
. moderate edema (raised approximately 1 millimeter) 3
. severe edema (raised more than 1 millimeter and extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 h, 48 h, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: day 8

Remarks on result:

other: Exposure of 3 minutes

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 h, 48 h, 72 h

Score:

0

Max. score:

4

Remarks on result:

other: Exposure of 3 minutes

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 h, 48 h, 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: day 8

Remarks on result:

other: Exposure of 1 hour

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 h, 48 h, 72 h

Score:

0

Max. score:

4

Remarks on result:

other: Exposure of 1 hour

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 rabbits

Time point:

other: 24 h, 48 h, 72 h

Score:

0.9

Max. score:

4

Reversibility:

fully reversible within: day 9

Remarks on result:

other: Exposure of 4 hours. Individual scores are : 1.0 - 0.0 - 1.7

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 rabbits

Time point:

other: 24 h, 48 h, 72 h

Score:

0

Max. score:

4

Remarks on result:

other: Exposure of 4 hours

Irritant / corrosive response data:

After a 3 minute exposure, a very slight erythema was observed from day 1 until day 7.
After a 1 hour exposure, a very slight to well-defined erythema was observed from day 1 to day 7
After a 4 hours exposure (three animals), a very slight erythema was observed on day 1 only in one animal, and from day 1 to day 4 in a second one. In the third treated animal, a well-defined erythema was observed from day 1 to 3, decreasing to a very slight erythema from day 4 to day 8.

Other effects:

Dryness of the skin was also noted:
After a 3-minute exposure (animal No. 569), from day 5 to 7;
After a 1 hour exposure (animal No. 569) on days 6 and 7
After a 4-hour exposure, from day 2 to day 11 in 1/3 animal.

After a 1-hour exposure (animal No. 569)
A dryness of the skin was noted on days 6 and 7.

After a 4-hour exposure (three animals)
Dryness of the skin was also noted in this last animal, from day 2 to day 11.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information but not classified Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP)

Conclusions:

Under the experimental conditions of this study, the test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, (batch No. T710/712) was slightly irritant when applied topically to rabbits.

Executive summary:

The objective of this study was to evaluate the potential of the test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, to induce skin irritation following a single topical application to rabbits according to OECD (No. 404, 24th April 2002) and Commission Regulation (EC) (No. 440/2008, B.4, 30 May 2008) guidelines.

The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

 

Methods

The test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit.

Since the test item was not severely irritant or corrosive to the skin on this first animal, it was then applied for 4 hours simultaneously to two other animals.

 

The quantity of the test item administered was 0.5 mL. The test item was placed on a dry gauze pad, which was then applied to an area of the skin of approximately 6 cm² of the animals. The gauze pad was held in place by a non-irritation semi-occlusive dressing and a restraining bandage. After required period of contact with the skin, the dressings were removed.

 

For each exposure period, cutaneous reactions were evaluated approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the reversibility of cutaneous reactions.

Body weight was recorded at the beginning and the end of the observation period. On completion of the observation period, the animals were sacrificed then discarded without macroscopic post‑mortem examination.

The mean values of the scores for erythema and edema were calculated for each animal.

 

Results

After a 3 -minute exposure (one animal)

A very slight erythema was observed from day 1 until day 7. Dryness of the skin was also noted from day 5 to 7.

 

After a 1 -hour exposure (one animal)

A very slight to well-defined erythema was observed from day 1 to day 7, associated with a dryness of the skin on days 6 and 7.

 

After a 4-hour exposure (three animals)

A very slight erythema was observed on day 1 only in one animal, and from day 1 to day 4 in a second one. In the third treated animal, a well-defined erythema was observed from day 1 to 3, decreasing to a very slight erythema from day 4 to day 8. Dryness of the skin was also noted in this last animal, from day 2 to day 11.

 

Mean scores over 24, 48 and 72 hours for each animal were 1.0, 0.0 and 1.7 for erythema and 0.0, 0.0 and 0.0 for edema.

Conclusion

Under the experimental conditions of this study, the test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate (batch No. T7110/712) was slightly irritant when applied topically to rabbits.